In a move that has generated intense debate among medical professionals, parents, and policymakers, the vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) is set to vote this week on whether to delay the hepatitis B vaccination for newborns in the United States. The meeting, scheduled for Thursday and Friday, December 4 and 5, 2025, follows months of controversy and marks a pivotal moment in the country’s approach to childhood immunization.
This policy review is no ordinary bureaucratic exercise. The committee, now led by Dr. Kirk Milhoan and entirely reconstituted by Health and Human Services Secretary Robert F. Kennedy Jr., is considering shifting the decades-old practice of administering the hepatitis B vaccine within 24 hours of birth—a recommendation that has been in place since 1991. The proposed change would delay the first dose until the infant is one month old, provided the mother tests negative for the virus. This could alter the immunization schedule for the roughly 3.5 million American children who are currently recommended to receive the shot on their first day of life, according to Reuters.
Robert F. Kennedy Jr., a long-time vaccine skeptic, has made his mark on federal vaccine policy since taking office. He replaced all 17 independent expert members of the Advisory Committee on Immunization Practices (ACIP) with his own nominees, many of whom are openly critical of current vaccine practices. According to The Hill, Kennedy has also overseen changes to the CDC’s website, including wording that undermines the scientific consensus on vaccines and autism, and has dropped recommendations for COVID-19 shots for pregnant women and children. These moves have drawn sharp criticism from major U.S. medical organizations and experts in infectious diseases.
The committee’s forthcoming vote has alarmed many in the medical community. Chari Cohen, president of the Hepatitis B Foundation, told The Hill, "It’s a good idea to review recommendations every now and then, especially if there has been new evidence coming out or new innovations in a particular field. And especially if that review is done systematically, methodically, scientifically and transparently. Right now, we have a situation where none of that has happened."
Medical professionals emphasize that hepatitis B is a highly contagious and incurable disease that can cause severe liver damage, cirrhosis, and cancer. The virus is transmitted through blood and bodily fluids—even in microscopic amounts—and can survive on surfaces for up to a week. Before the vaccine became widely available in the 1980s, outbreaks claimed the lives of young children with heartbreaking speed, as recounted by liver specialist Brian McMahon in the Los Angeles Times. McMahon recalled treating a 17-year-old girl and an 8-year-old boy who both died from liver cancer linked to hepatitis B, having contracted the virus at birth or in early childhood. "That outcome is now preventable," he said, underscoring the vaccine’s critical role.
The birth dose of the hepatitis B vaccine is up to 90% effective in preventing infection from the mother if given within the first 24 hours of life. When babies complete the full three-dose series, 98% develop immunity lasting at least 30 years. In communities like western Alaska, targeted vaccination campaigns have led to a dramatic decline in cases. "Liver cancer has disappeared in children," McMahon noted. "We haven’t seen a case since 1995. Nor do we have any children under 30 that have gotten infected that we know of."
Despite these successes, the committee is weighing arguments for delay. Dr. Milhoan, the new committee chair, stated, "We try to avoid giving things to the most vulnerable. We want to test these things incredibly thoroughly before we give it to them, especially in a neonatal period or in a pregnant mother." His position reflects a broader skepticism among some committee members about vaccinating newborns, particularly when mothers test negative for hepatitis B.
But the risks of delay are substantial, according to experts. Cohen pointed out that 70% of people living with hepatitis B in the U.S. are undiagnosed. "We don’t know when babies go home, who’s going to be caring for them, whether it’s in the house, in the neighborhood, in the community, in daycare. We don’t know who has hepatitis B or not, and we shouldn’t have to rely on that." Moreover, the CDC estimates that 16% of pregnant women are unaware of their hepatitis status, making reliance on maternal testing alone unreliable.
Medical organizations, including the American Academy of Pediatrics, warn that delaying the birth dose could result in more children contracting the virus. Cody Meissner, an ACIP member, cautioned, "We will increase the risk of harm based on no evidence of benefit, because there will be fewer children who will get the full hepatitis B vaccine series." Modeling by HepVu, the Hepatitis B Foundation, and the National Viral Hepatitis Roundtable predicts that a two-month delay could result in 238 additional infections among children and $21.6 million in added healthcare costs.
Experts also highlight the broader consequences of changing the schedule. The hepatitis B vaccine is often administered as part of a combination shot with vaccines against polio, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b. John Grabenstein, a former Merck executive, told Reuters, "This is what I call the tyranny of just-in-time inventory. To maximize efficiency, they will have minimized their stockpile, and if there’s an abrupt change, it could lead to shortages." Vaccine makers Merck, GSK, and Sanofi have warned that changes could disrupt supply for a year or longer, potentially leaving children unprotected against multiple diseases.
Meanwhile, the evidence supporting the current policy remains robust. A review of over 400 studies by the Center for Infectious Disease Research and Policy and the Vaccine Integrity Project, released Tuesday, found that giving the hepatitis B vaccine at birth reduced infections in children by more than 95%. The report concluded, "The hepatitis vaccine has consistently been shown to be a safe vaccine, regardless of timing of vaccination. No benefits of vaccine efficacy, effectiveness, or long-term protection were identified in delaying the first dose compared with vaccination at birth."
Still, misinformation and skepticism persist. Some parents, influenced by public figures and online rumors, question the need for vaccinating healthy newborns—especially for a virus they associate only with risky behaviors. But as William Schaffner, professor of preventative medicine at Vanderbilt University, explained, "If you wait a month and if the mom happens to be positive, or the baby picks it up from a caregiver, by that time the infection is established in that baby’s liver. It’s too late to prevent that infection." Babies who receive the full vaccine series from birth have their risk of liver cancer reduced by 84%.
As the committee prepares to vote, the stakes are high. Delaying the birth dose could reverse decades of progress, increase preventable infections, and sow further distrust in public health. For now, most medical experts urge parents to consult their doctors and rely on the overwhelming evidence supporting the safety and effectiveness of the hepatitis B vaccine at birth. The outcome of this week’s meeting will likely have lasting implications for the health of America’s children and the integrity of its public health policy.
